Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT07040293
Eligibility Criteria:
Inclusion Criteria:
* Participants must be aged between 18 and 75 years, with no restrictions on gender.
* Participants with conditions such as single-segment lumbar intervertebral disc protrusion, lumbar spondylolisthesis, and lumbar spinal stenosis who are scheduled to undergo posterior decompression, intervertebral fusion, and internal fixation surgery.
* Participants must be able to comprehend the objectives of the study, willingly participate, and provide informed consent by signing the consent form.
Exclusion Criteria:
* Individuals with a hemorrhagic predisposition or coagulation disorders, indicated by a prothrombin time (PT) of 18 seconds or greater, and those with a history of prolonged anticoagulant use.
* Individuals presenting with lumbar spine infections or fractures.
* Individuals with known allergies to materials such as polyethylene glycol, sodium carboxymethyl cellulose, and bone wax (including beeswax, paraffin, and isopropyl palmitate).
* Individuals whose conditions are critical, making it challenging to accurately assess the efficacy and safety of the equipment.
* Individuals deemed by researchers to have poor compliance, rendering them unable to fulfill the study requirements.
* Women who are currently pregnant, intend to become pregnant within the past year, or are breastfeeding.
* Individuals who have participated in other clinical trials within the preceding 30 days to prevent cross-interference.
* Individuals with significant complications or comorbidities, such as severe cardiovascular, hepatic, renal, or other chronic conditions that could influence surgical risks and research outcomes.
* Individuals identified by researchers as having a life expectancy of less than six months.
* Individuals with severe osteoporosis, defined as a bone mineral density T-score of ≤-2.5 accompanied by fragility fractures.
* Any other individuals deemed unsuitable for participation in this clinical trial by the researchers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07040293
Study Brief:
Protocol Section:
NCT07040293